United StatesPhilips CT systems affected include Brilliance models (Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP) with Software 4.1.10.x and product codes 728306, 728305, 728311; IQon Spectral CT (product codes 728332, 728331) with Software 4.7.7.x; Ingenuity CT variants (728327, 728324, 728325) with Software 4.4.10.x; and Brilliance CT 64 Channel (728231, 728232) with Software 4.1.10.x. Philips identified an unintended radiation issue with the IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect equipment performance; the recall covers units sold in the United States and U.S. territories.
What's being recalled
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Recalling firm: Philips North America Llc, Cambridge, MA, United States.
How to identify it
UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A. UDI:N/A UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.
The hazard
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US and US Territories.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)